ULTRAsound-assisted Catheter-guided Thrombolysis for Intermediate-high Risk Patients With PE

Pulmonary embolism (PE) is a life-threatening condition and a leading cause of cardiovascular mortality. While systemic thrombolysis is the standard treatment for high-risk PE, its bleeding risk limits use in some patients, highlighting the need for alternative reperfusion strategies such as catheter-directed thrombolysis (CDT). This prospective study will evaluate the safety and efficacy of CDT using the EkoSonic Endovascular System (EKOS; Boston Scientific) in patients with intermediate-high and high-risk PE. The primary outcome is all-cause mortality through 360 days of follow-up, with secondary outcomes including changes in echocardiographic parameters such as the RV/LV diameter ratio.

NCT Number	NCT07452991
Lead Sponsor	National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Conditions	Pulmonary Embolism (PE)
Enrollment	300 participants
Start Date	2024-09-10
Primary Completion	2029-09-10 (estimated)
Study Completion	2030-09-10 (estimated)
Updated on ClinicalTrials.gov	2026-03-17